MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3085 SURGICAL TABLE

Lot Number 0400219078

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the table and found the table to be operating properly, no repairs were required.While onsite, the technician learned that the table had an arthrex hds well leg spar long assembly attached at the time of the reported event.The technician was able to duplicate the reported event with the attachment installed.The 3085 surgical table operator manual states (1-2), "warning instability hazard: possible patient or user injury, as well as table or accessory failure, may result from using steris table accessories for other than their stated purpose or from using, on steris tables, accessories manufactured and sold by other companies." steris is not the manufacturer or distributor of the arthrex hds well leg spar - long assembly.Steris notified the manufacturer, arthrex, of the reported event to internally investigate and evaluate for reportability in accordance with 21 cfr part 803.The technician counseled user facility personnel on the proper use and operation of the 3085 surgical table, specifically to not use the arthrex hds well leg spar long assembly with their table.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure the doctor applied force to their 3085 surgical table when the table lifted off of the floor.The table was stabilized and the procedure was completed successfully.No report of injury or procedure delay.

• Brand Name: 3085 SURGICAL TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 13046420
• MDR Text Key: 290151009
• Report Number: 1043572-2021-00091
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 0400219078
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1